Our most advanced oncology drug candidate is Pracinostat, a potential best-in-class oral histone deacetylase (HDAC) inhibitor. Following positive results from a Phase II clinical study in acute myeloid leukemia (AML), Pracinostat is poised to move into an international Phase III study in patients with newly diagnosed AML who are unfit to receive induction therapy.
In August, we entered into an exclusive licensing, development and commercialization agreement with Helsinn Healthcare, SA, a Swiss pharmaceutical group focused on building quality cancer care products. The deal provides the complementary resources from both organizations to rapidly advance Pracinostat into the Phase III AML study and expand into additional indications, including high-risk myelodysplastic syndrome (MDS).
Under the terms of the agreement, Helsinn was granted exclusive worldwide rights to Pracinostat and is responsible for funding its global development and commercialization. As compensation, we receive near-term payments totaling $20 million and will be eligible to receive up to an additional $444 million in potential regulatory and sales-based milestones, along with royalty payments on the net sales of Pracinostat.
Including MDS along with AML in the development plans was a critical component to this deal, as it significantly increases the market opportunity for Pracinostat. David Urso, JD, Senior Vice President, Corporate Development & General Counsel
As part of the development and commercialization agreement, we are also collaborating with Helsinn to explore an optimal dosing regimen of Pracinostat in combination with azacitidine for the treatment of high-risk MDS. Based on our own clinical experience with the combination, we believe that an optimized dose and schedule may show considerable promise in MDS, an indication with a significantly higher addressable patient population than that of AML. This Phase II clinical study is anticipated to commence in the first half of 2017.
Helsinn is an ideal strategic partner for Pracinostat, with the capital resources to aggressively fund its late-stage clinical development and the commercial organization to market the drug. In addition to a strong commercial presence in the U.S., Helsinn has created a significant global network of 70 commercial partners in 90 countries. The company’s market leading antiemetic, Aloxi®, is often used by patients receiving azacitidine, so its commercial organization is already well positioned to market Pracinostat. Most importantly, Helsinn shares our enthusiasm for improving the lives of patients with cancer and bringing Pracinostat to those in need.